MAUDE Adverse Event Report: COOK INC TURBO-JECT® DOUBLE LUMEN BEDSIDE POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	G23903
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported, a turbo-ject® double lumen bedside power-injectable picc line inserted on the (b)(6) 2018.The picc line was found to be split at the hub (was aspirating air) and was removed on (b)(6) 2019.This required a new picc line to be inserted.Additional information was received on (b)(6) 2019.The customer is not aware of any other devices being attached to the hub.Flushing protocol was pre and post medications as well as once per shift if not in use.
Additional Manufacturer Narrative
Additional information: investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and trends.One device was returned for investigation.Visual examination noted the clear tubing is partially separated at the purple hub.A review of the device history record for lot number 8858748 found there were no non-conformances related to the reported failure mode.A review of complaint history revealed this complaint to be the only one associated with complaint lot number 8858748.The instructions for use (ifu) the proper warnings, precautions, and instructions for use.The ifu has specific warnings about power injector pressure - the safe and effective use of turbo-ject picc lines with power injector pressures set above 325 psi has not been established.Do not power inject if maximum injection rate cannot be verified to meet limit printed on catheter hub or extention tube.The complaint was confirmed based upon evaluation of the returned device.The assigned root cause category for this failure mode is - cause traced to device design.Measures have been initiated to address this failure mode.The appropriate internal personnel have been notified and cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new event information to report.

• Brand Name: TURBO-JECT® DOUBLE LUMEN BEDSIDE POWER-INJECTABLE PICC
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8290877
• Report Number: 1820334-2019-00270
• Device Sequence Number: 19319506
• Product Code: LJS
• UDI-Device Identifier: 00827002239036
• UDI-Public: (01)00827002239036(17)200502(10)8858748
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2020
• Device Model Number: G23903
• Device Catalogue Number: UPICDS-5.0-CT-40NT-1111
• Device Lot Number: 8858748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 73